Download Drugs: ACP Policy Compendium - American College of Physicians

*ACP policy originating from ACP sponsored resolution introduced to the AMA House of
Delegates
DRUGS
Medicare Prescription Drug Coverage
1. Medicare Part D should be financed in such a way as to bring in sufficient revenue to support the
costs of the program, both short and long-term, without further threatening the solvency of the
Medicare program or requiring cuts in payments for other services or reduced benefits in other
areas. Given the anticipated high cost of a prescription drug benefit, Congress must assure that
revenues for financing the benefit do not depend on overly optimistic assumptions about tax
revenues resulting from growth in the economy or under-estimates of the costs of the benefit. A
predictable and stable source of financing, which will assure that revenues keep pace with the
costs of the benefit without requiring cuts in other benefits, should be identified. If it turns out
that costs in future years exceed anticipated revenues, Congress will need to consider making
adjustments in the benefit and/or financing mechanism to assure that prescription drug coverage
can be sustained without requiring cuts in other benefits.
2. ACP believes that the highest priority should go toward providing prescription drug benefits for
those most in need: low income beneficiaries who do not have access to drug coverage under
other plans. Funding of programs to assist low-income Medicare beneficiaries in paying their
Part D costs, such as the low-income subsidy, should be provided and adjusted as needed. The
federal government should improve its efforts to alert qualified beneficiaries of their eligibility to
receive financial assistance related to Part D cost-sharing.
3. While ACP strongly prefers that the Government not require the use of formularies for covered
prescription drugs, existing Medicare Part D formularies should operate in a way consistent with
ACP policies on drug formularies.
4. A method of pricing Medicare payments for prescription drugs should be included that will
balance the need to restrain the cost of the benefit with the need to create financial incentives for
manufacturers to continue to develop new products. Rigid price controls that will discourage
innovation should be rejected.
5. Physicians should continue to be able to prescribe covered drugs for accepted off-label uses.
6. The prescription drug benefit should not require an expansion of prescribing privileges for nonphysician health professionals beyond what can be supported based on their level of training.
7. Issues of generic and therapeutic substitution under the Medicare program should be addressed in
a way that is consistent with existing ACP policies on those issues. (BoR7-99, revised BoR 10)
Honoring of Primary Care Physicians’ Prescriptions by the VA Medical System
ACP advocates for legislative and regulatory changes that allow non-VA physicians’ prescriptions for
eligible patients to be filled by pharmacy services within the Department of Veterans’ Affairs facilities.
(BoR 04)
Methadone Regulation
The American College of Physicians (ACP), recommends that Methadone be considered no differently
than any other DEA Schedule II agent. (BoR 4-99, reaffirmed BoR 10)
Improving FDA Regulation of Prescription Drugs
1. Improve the FDA's ability to approve and monitor prescription drugs through increased funding.
2. Increase the FDA's capacity to regulate drugs manufactured outside the U.S. through both
appropriations and user fees.
3. The FDA's regulatory authority should be expanded and more clearly exercised in the design of
preapproval trials and studies. Design of preapproval trials should include at least the following:
• A sample size large enough to reflect an appropriate distribution of age and comorbidity
among subjects.
• Similar priority given to evaluating both drug safety and efficacy
• Use of scientific and technological tools (such as pharmacogenetics and computer
simulations) to provide earlier warnings about drug toxicities and potential harm.
• Mandatory registration and public reporting of all clinical trial results.
4. Bundling of drugs to limit marketability and availability should be prohibited.
5. Improve the adverse events reporting system.
6. Grant the FDA the authority to require that newly approved drugs have a special symbol on their
labels to help increase public awareness that they are new, and limit direct-to-consumer (DTC)
advertising for the first 2 years after approval. (BoR 10)
FDA Regulation of Drugs and Medical Devices
ACP opposes any efforts to weaken FDA authority to demand rigorous evaluations of drugs and medical
devices for both safety and effectiveness based on sound scientific and medical evidence and opposes
legislative attempts to curtail FDA authority to establish and maintain standards of safety and
effectiveness for approval of drugs and medical devices. (ACP AMA Del A-95; reaffirmed BoR 08)
Removal of Drugs by the Food and Drug Administration (FDA)*
ACP recommends that the FDA inform the medical profession of the evidence for the need to withdraw
drugs of long standing use prior to implementation of such an order and there shall be opportunity and
time for a response by the medical profession except in instances of immediate threat to life and well
being. Consideration should be given to the experiences, views and opinions of physicians in the clinical
practice of medicine before condemning or removing drugs from the market. (HoD 71; revised HoD 73;
reaffirmed HoD 87; reaffirmed BoR 04)
Statement of the American Pharmaceutical Association (APA) and ASIM on Prescriptions*
Introduction
Historically, the pharmaceutical and medical professions have devoted considerable time and effort to the
development and rational utilization of safe and effective drugs for the treatment and prevention of
illness. Today, that successful effort continues, helping to achieve the highest standards of health in the
world for the American people. But in order to gain maximum benefit from the use of drugs while minimizing their adverse side effects, prescribers and pharmacists must maintain effective communications
not only among themselves, but with their patients as well. The directions for drug use and other information which prescribers indicate on prescription orders and which pharmacists transfer to prescription
labels are critical to safe and effective drug therapy. In order to assure that this information is conveyed
clearly and effectively to patients, the following guidelines have been developed by the APA and ASIM.
Guidelines for Prescribers
The following guidelines are recommended for prescribers when writing directions for drug use on their
prescription orders: The name and strength of the drug dispensed will be recorded on the prescription
label by the pharmacist unless otherwise directed by the prescriber. Whenever possible, specific times of
the day for drug administration should be indicated. (For example, "Take one capsule at 8:00 am, 12:00
noon, and 8:00 pm" is preferable to "Take one capsule three times daily." Likewise, "Take one tablet two
hours after meals" is preferable to, "Take one tablet after meals.") The use of potentially confusing
abbreviations, i.e., quid, qod, qd, etc., is discouraged. Vague instructions such as, "Take as necessary," or,
"Take as directed," which may be confusing to the patient, are to be avoided. If dosing at specific
intervals around-the-clock is therapeutically important, this should specifically be stated on the
prescription by indicating appropriate times for drug administration. The symptom, indication or intended
effect for which the drug is being used should be included in the instructions whenever possible. (For
example, "Take one tablet at 8:00 am and 8:00 pm for high blood pressure," or, "Take one teaspoonful at
8:00 am, 3:00 pm and 6:00 pm for cough.") The metric system of weights and measures should be used.
The prescription order should indicate whether or not the prescription should be renewed and, if so, the
number of times or the period of time such renewal is authorized. Statements such as "Refill prn" or
"Refill ad lib" are discouraged. Either single or multi-drug prescription forms may be used when
appropriately designed, and pursuant to the desires of local medical and pharmaceutical societies.
(reaffirmed HoD 87; reaffirmed BoR 04) When institutional prescription blanks are used, the prescriber
should print his or her name, telephone number, and registration number on the prescription blank.
Guidelines for Pharmacists
Pharmacists should include the following information on the prescription label: name, address and telephone number of pharmacy; name of prescriber; name, strength and quantity of drug dispensed (unless
otherwise directed by the prescriber); directions for use; prescription number; date on which prescription
is dispensed; full name of patient; any other information required by law. Instructions to the patient
regarding directions for use of medication should be concise and precise, but readily understandable to the
patient. Where the pharmacist feels that the prescription order does not meet these criteria, he or she
should attempt to clarify the order with the prescriber in order to prevent confusion. Verbal reinforcement and/or clarification on instructions should be given to the patient by the pharmacist when
appropriate. For those dosage forms where confusion may develop as to how the medication is to be
administered (for example, oral drops which may be mistakenly instilled in the ear, or suppositories
which may be mistakenly administered orally), the pharmacist should clearly indicate the intended route
of administration on the prescription label. The pharmacist should include an expiration date on the
prescription label when appropriate. Where special storage conditions are required, the pharmacist should
indicate appropriate instructions for storage on the prescription label.
Conclusions
Communicating effective dosage instructions to patients clearly and succinctly is a responsibility of both
the medical and pharmaceutical professions. Recent studies documenting the low order of compliance
with prescription instructions indicate that inadequate communication between the medical and
pharmaceutical professions and poor comprehension by the public may be causative factors. The APA
and ASIM believe that the guidelines as stated above will serve as an initial step toward patients
achieving a better understanding of their medication and dosage instructions. The two organizations urge
state and local societies representing pharmacists and prescribers to appoint joint committees for the
purpose of refining these guidelines further as local desires and conditions warrant. Cooperative efforts
between the professions are essential to good patient care and significant progress can be made in other
areas by initiating discussions between the two professions concerning common interests and goals.
(HoD 74; reaffirmed HoD 87; reaffirmed BoR 04)
DRUGS: ADVERTISING
Direct-to-Consumer Prescription Drug Advertising
Position 1: ACP believes that direct-to-consumer advertising of prescription drugs is an inappropriate
practice that undermines the patient-physician relationship and often leaves patients confused and
misinformed about medications.
Position 2: In the absence of legislation or regulation to ban DTC advertising, the FDA should play a
stronger role in ensuring that complete, valid, and clear information is provided to the public and in
making determinations about whether the commercial information in a DTC ad actually will educate and
enhance the health of the public. ACP calls on the federal government to expeditiously strengthen
regulations governing DTC ads in the following ways:
Congress should give the FDA the authority to issue regulations that require review and approval
of the content of any DTC advertisement prior to it being released to the public.
Congress should provide additional resources for the FDA to carry out enhanced oversight and
enforcement duties and to study the effectiveness of DTC advertising.
Congress should give the FDA the authority to regulate “reminder” and “help-seeking” ads.
The FDA should require at least a two-year moratorium on DTC advertising for newly launched
prescription drugs to allow for appropriate monitoring and regulation of drug safety and efficacy.
Federal regulations should require manufacturers to run corrective ads after receiving both
“untitled” and “warning” letters.
The FDA should take steps toward regulating image selection in ads.
The FDA should require that information about a drug’s effectiveness, side effects, and
contraindications, as well as references to where more comprehensive information can be
obtained, be prominently displayed in ads and on labeling and be in a language that is clear and
understandable to the general public.
The FDA should require that ads provide key information to consumers on alternative treatments,
such as lifestyle changes.
DTC ads should be required to contain a statement directing patients to report all adverse reactions
to a physician and the FDA at MedWatch, and give the toll-free telephone number and Web
address of MedWatch.
The FDA should require that ads for those drugs approved on the condition of further studies
publicly identify that safety concerns have been identified and are being investigated.
The federal government should sponsor public service ads that do not mention particular
treatments, but instead are aimed at increasing the public’s awareness of various under-treated
diseases.
Federal regulations should prohibit the use of DTC ads to promote controlled substances.
Position 3: ACP recognizes the value of patient education and supports public and private efforts to make
patients—particularly older patients— aware of diseases/conditions, treatment options, indications, and
contraindications. The FDA, in cooperation with the medical profession, the pharmaceutical industry, and
the pharmacy industry, must further evaluate, define, and measure the impact of DTC ads on patients and
physicians and identify ways to ensure that patients and physicians are provided with complete, truthful,
and non-confusing health information. (BoR 04-06)
DRUGS: IMPORTATION
Reimportation
ACP supports legislative and/or regulatory measures to develop a process to ascertain and certify the
safety of reimported prescription drugs. (revised BoR 05)
Recommendation 1: Action is needed, including consideration of drug importation, to reduce the high
cost of prescription drugs in the United States. However, assuring high quality and patient safety must
remain the top priority of any cost control program.
Recommendation 2: Before legalizing the importation of prescription drugs, Congress should:
Permit state pilot programs to test the safe implementation of prescription drug importation
programs. Trials could initially be aimed at individuals without drug coverage. The results of
such pilots should serve as a model for the federal government and individual states.
Create an independent FDA oversight board to handle drug safety issues, including those related
to prescription drug importation, and to communicate more effectively with patients and
physicians about the risks and benefits of such medications.
Study and report on the effectiveness of promising new and emerging anti-counterfeiting
technologies, such as radio frequency chips to track drug shipments. Nevertheless, it should be
recognized that widespread adoption of authentication technologies is a daunting task that could
raise the cost of imported drugs, thereby reducing any expected savings from importation.
Urge the expansion of accreditation programs. In particular, ACP urges the NABP to consider
applying its Internet pharmacy accreditation program on an international level to help consumers
identify legitimate Internet pharmacies.
Enhance resources of the FDA to inspect facilities manufacturing prescription drugs for export to
the U.S. and enhance resources of the FDA, the U.S. Customs Service, law enforcement agencies,
and other federal agencies involved in assuring that products that are illegal, are counterfeit, or do
not meet U.S. safety and quality standards are not allowed into the U.S.
Recommendation 3: ACP believes that any drug importation system that Congress approves should:
Be a closed system, in which participating pharmacies and Internet sites must meet FDA
standards;
Have a tightly controlled and documented supply chain;
Not include controlled substances, biologics, or products that are infused/injected or products that
are photo reactive or have strict temperature requirements;
Be limited to countries that meet U.S. standards to assure high quality and patient safety of
imported drugs;
Include adequate resources for inspections of facilities and enforcement of U.S. requirements; and
Require that only prescriptions written by a U.S.-licensed physician with an established
professional relationship with the patient be accepted for importation.
Recommendation 4: Prescription drug importation is not a long-term solution to the high cost of
prescription drugs, which is having a detrimental effect on Americans’ access to life-saving therapies.
ACP urges the federal government to take immediate action to improve access to pharmaceuticals by:
Assuring there are sufficient incentives for pharmaceutical research and development;
Encouraging increased competition among brand-name manufacturers;
Speeding the approval and encouraging the use of generic drugs;
Negotiating volume discounts on prescription drug prices and pursuing prescription drug bulk
purchasing agreements under the Medicare program;
Expanding the availability of public and private sector health insurance that includes coverage for
prescription drugs;
Encouraging pharmaceutical manufacturers to expand their patient assistance and drug discount
programs and increase patient education for these programs;
Protecting state pharmaceutical programs that may be impacted by the new Medicare law;
Reviewing recent increases in the cost of pharmaceuticals;
Studying the effectiveness of prescription drug substitutes, such as lower-cost, therapeutically
equivalent medications;
Encouraging and helping to implement disease management programs;
Encouraging the use of evidence-based medicine; and
Considering limits on direct-to-consumer drug advertising. (BoR 05)
Controlling Health Care Costs: Ensure Accurate Pricing of Services
1.
The Federal government should take action to reduce the high cost of prescription drugs in the
United States by using its purchasing power to obtain the best prices from pharmaceutical
manufacturers covered by publically funded plans, including Medicare, similar to the prescription
drug purchasing process used by the Veterans Administration. However, ensuring high quality
and patient safety and support for continued innovation and research on drugs that can advance
medical care must remain the top priority of any program to address the price of prescription
drugs. Prescription drug importation is not a long-term solution to the high cost of prescription
drugs. Efforts to reduce prescription drug prices should include:
a. Encouraging increased competition among brand-name manufacturers
b. Studying the effectiveness of prescription drug substitutes, such as lower-cost,
therapeutically equivalent medications and expediting approval of generic drugs and
encouraging their use
c. Negotiating volume discounts on prescription drug prices and pursuing prescription drug
bulk purchasing agreements under the Medicare program
d. Encouraging pharmaceutical manufacturers to expand their patient assistance and drug
discount programs and increase patient education for these programs.
DRUGS: LABELING AND PACKAGING
Pharmacy Labeling*
In order to reduce patient confusion and the potential for therapeutic errors, ACP calls upon pharmacy
organizations, mail-order pharmacies, national pharmacies to label prescriptions with both the generic
drug name and brand name substituted for. (HoD 93; reaffirmed BoR 04)
Quality Assurance and Labeling*
ACP believes that appropriate action should be taken to ensure that, through federal regulations or laws,
all pharmaceutical manufacturers be required to perform effective and meaningful ongoing quality
assurance studies of the biologic efficacy and purity of prescription medications they are marketing.
(HoD 89; reaffirmed BoR 04)
DRUGS: PRESCRIBING AND DISPENSING
Drug Formularies and Pharmacy Benefit Management
Formularies
1. ACP opposes any formulary that may operate to the detriment of patient care, such as those
developed primarily to control costs.
2. Decisions about which drugs are chosen for formulary inclusion should be based upon the drug’s
effectiveness, safety, and ease of administration rather than solely based on cost.
3. Evaluation of physician prescribing patterns (i.e., drug utilization review) should give priority to
the effectiveness, and safety and ease of administration of the drugs prescribed rather than solely
based on costs.
4. ACP recommends that financial incentive arrangements should be linked to cost-effective
practices rather than formulary compliance.
5. ACP opposes financial arrangements that place the physician’s financial interest in conflict with
his or her patient’s well-being.
6. ACP recommends that formularies should be constructed so that physicians have the option of
prescribing drugs that are not on the formulary (based on objective data to support a justifiable,
medically indicated cause) without cumbersome prior authorization requirements.
7. ACP recommends that a patient information program be instituted by Managed care plans to
make patients aware of formulary utilization and any associated costs such as co-pays.
8. Patient formulary education should include how the formulary functions, and a discussion of how
co-payment and/or deductible requirements may affect their pharmacy benefit.
9. ACP supports prompt prior notification to patients and physicians when formularies are changed
or discontinued.
10. ACP recommends such notification be given within a specified time period, not fewer than ninety
(90) days prior to change implementation.
11. Formularies should be approved on a regional basis by a professionally qualified body which
includes practicing physicians using that formulary.
12. ACP recommends that Pharmacy &Therapeutic (P&T) Committees be representative of, and have
the support of, the medical staffs that will utilize the formulary.
13. ACP supports industry moves to develop technology to make formularies more accessible and
easier to utilize. ACP recommends physician input in designing, and pre-testing of, these
technologies.
14. ACP supports continued government and industry studies of the impact of formularies on patient
care. ACP recommends that CMS and states develop annual report-cards on the impact of
formularies on beneficiaries enrolled in Medicare managed care plans.
15. Prescribing patterns should be influenced primarily through educating physicians on safety and
efficacy. Cost should be a determinant only when safety and efficacy are equal among specific
drug choices.
Pharmacy Benefit Management
1. ACP supports government regulation and industry self-regulation of Pharmacy Benefit Managers
(PBMs). ACP particularly supports close government oversight of mergers between PBMs and
pharmaceutical manufacturers.
2. ACP supports the disclosure to patients, physicians, and insurers of the financial relationships
between PBM companies, pharmacists, and pharmaceutical manufacturers.
3. ACP supports requiring that PBM organizations’ requests to alter medication regimes should
occur only when such requests are based on objective data supported by peer reviewed medical
literature and which undergo review and approval of associated Managed care plans’/MBHOs’ P
& T Committees.
4. ACP supports requiring that, with a patient’s consent, PBM organizations be required to provide
treating physicians with all available information about the patient’s medication history. (BoR 00,
reaffirmed 11)
Internet Prescribing
The ACP advocates that a direct physician patient relationship remain inviolate and that the use of the
Internet for prescribing should facilitate, not circumvent that relationship, and that Internet prescribing
should be used only in the context of an established physician-patient relationship. (BoR 10-99,
reaffirmed BoR 10)
Misuse of DEA Numbers*
ACP, in order to protect confidentiality and minimize administrative burdens on physicians, supports the
AMA policy to eliminate requirements by pharmacies, prescription services and insurance plans to
include physicians’ DEA numbers on prescriptions written for non-controlled drugs. (HoD 95, reaffirmed
BoR 10)
Mail Order Pharmacy Confidentiality*
ACP opposes the use of confidential prescribing data by third parties to directly contact patients for any
purposes. (HoD 93; reaffirmed BoR 04)
Negative Formularies
Resolved, that the Board of Regents encourage the deletion of drugs from Negative Drug Formularies for
which there exist FDA A-rated generic substitutes. (BoR 00)
Proper Use of Accepted Drugs*
ACP believes that physicians in clinical practice are best suited to determine the proper usage of accepted
drugs, and professional judgment should not be restricted by legislative or administrative fiat. Physicians
should be permitted to use already approved drugs in any manner consistent with prudent medical
judgment. (HoD 78; revised HoD 89; reaffirmed BoR 04)
Physician Drug Dispensing*
ACP believes that patients should be informed that they have the right to have their prescription filled at a
pharmacy of their choice. However, physicians should have the option to dispense medication in their
offices, especially when it is to the medical or economic advantage of their patients. Under no
circumstances should physicians who dispense medication place their own financial interest above the
welfare of their patients. (HoD 87; reaffirmed BoR 04)
Behind the Counter Drugs
The College’s believes that the current two-drug category system of prescription-only and over-thecounter (O-T-C) drugs formalized by Congress under the Durham-Humphrey’s Amendment to the Food,
Drug and Cosmetic Act is effective in ensuring safe and accessible medications to the population. The
current system allows for the general availability within the O-T-C market of those drugs suitable for selfmedication that also require no medical monitoring and have a low potential for significant adverse side-
effects, overdose or abuse. Furthermore, it appropriately requires the intervention of a physician,
specifically trained in the diagnosis and treatment of medical conditions, to serve as the intermediary prior
to having access to medications that don’t meet the O-T-C conditions.
The College believes that the B-T-C drug category under consideration offers little evidence of improving
the current two-category system and poses increased patient-safety concerns. More specifically, the
College opposes the implementation of a B-T-C drug category for the following reasons:
The pharmacist does not have the necessary training to serve as the intermediary to drugs that fall
outside the current O-T-C requirements—Many of the medications being considered for potential
inclusion in this B-T-C category (e.g. cholesterol-lowering drugs, drugs for the treatment of
asthma) relate to conditions that require the taking of a skilled medical history, a physical exam,
and the use of laboratory results to ensure that an accurate diagnosis is made and the most
appropriate medication is used. The pharmacist, while skilled in areas of drug effects and
interactions, does not have the adequate training to provide these diagnostic and treatment
considerations.
The pharmacist may not have time in their current schedule of activities to even perform limited
counseling or educational expectations—The experience of many of our members is that most
pharmacists are already having difficulties meeting their current drug dispensing demands. These
increased demands are fueled by current demographics and the implementation of the Medicare
Part D benefit. It is unclear whether the typical pharmacist would be able to adequately meet even
minimal additional intervention requirements.
The consideration of a B-T-C drug category raises a number of questions that must be addressed
prior to any consideration of implementation—The FDA Notice of Comment includes a large
number of questions that currently have no suitable answer regarding the potential
implementation of a B-T-C drug category. These include questions pertaining to the criteria for a
drug to be treated as a B-T-C, the appropriate role of the pharmacist and the training required, and
the type of documentation that would be required. Additional issues not included in the Notice
that need to be considered include the process by which the patient’s personal physician would be
notified regarding this medication intervention to ensure appropriate subsequent care, the
pharmacist’s responsibility to provide follow-up consistent with their intervention, and the extent
the pharmacist would be legally liable for their actions during this encounter.
There is no currently available data supporting the contention that a B-T-C drug category would
safely increase access, lower cost, or generally effect improvement to our current two-category
system—As you are aware, the most comprehensive study of this issue was a 1995 Government
Accounting Office (now the Government Accountability Office) study 1 that examined
international (and the limited national) experience with a B-T-C drug category. The results
reflected that there was no clear pattern of increased or decreased access, that the counseling
conducted by pharmacists was infrequent and incomplete and that any safeguards provided to
deter drug abuse were easily circumvented. The study concluded that “the evidence that is
available tends to undermine the contention that major benefits are obtained in countries that have
such a class.” The College is aware of no evidence in the current literature to refute this
conclusion.
The College is not opposed to the FDA’s expanding of the limited number of drug exceptions to the twocategory system that were recently implemented for non-medical reasons and require only an
administrative intervention on the part of the pharmacist. Examples of this include the recent
implementation of a proof-of-age requirement prior to the dispensing of a Plan B emergency
contraceptive, which was motivated by social /legislative concerns and the signature requirement and
quantity limitations coupled to the dispensing of drug products with pseudoephedrine, which was
motivated by concerns related to its use as a key ingredient to the production of methamphetamine.
DRUGS: SUBSTITUTION
Use of "A" Rated Generic Drugs*
ACP will petition the FDA or other appropriate agency to develop a national system that would allow
physicians who permit generic substitution to designate substitution by only "A" rated generic drugs;
require any prescription medication crossing state lines, such as those as part of a prescription filled by an
out-of-state pharmacy, to use only "A" rated generic drugs if brand name is not required by the
prescribing physician; and require a national uniform policy regarding a phrase that can be used to denote
the need for a brand name drug. (HoD 94; reaffirmed BoR 04)
Drug Product Selection and/or Substitution*
ACP opposes therapeutic substitution in an outpatient setting without the prescribing physician's consent.
ACP physicians should prescribe generically when therapeutic equivalency, therapeutic safety and
bioavailability are established. Physicians should carefully consider the advice of the pharmacist and use
his or her knowledge and experience regarding selection of drug product alternatives that could result in
cost savings to the patient. When therapeutic equivalency and bioavailability of alternative generic drug
products are assured, then the privilege of drug product selection may be delegated to the pharmacist.
Any generic drug product selected by the pharmacist must be therapeutically equivalent and bioavailable
and should result in cost savings to the patient. The physician, at his or her discretion, must at all times
have the authority to specify in some simple manner the source of the drug product to be dispensed. (HoD
79; HoD 88; revised HoD 93; reaffirmed BoR 04)
Generic Drug Prescriptions*
ACP believes that the Food and Drug Administration and other state regulatory agencies should require
that generic drugs be held to the same standards as the trade name drug. (HoD 90; reaffirmed BoR 04)